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Micronutrient Dose Response Study in Bangladesh

Study acronym: MiNDR
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion moved earlier from Sep 22, 2025 to Apr 18, 2025 Show 5 more changesShow less
    • Study completion pushed from Sep 30, 2026 to Dec 31, 2027
    • Secondary endpoints: details revised at 11 of 11 entries
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 4 words
    • Study description expanded, about 3 words
  2. Enrollment target: estimated 650 to confirmed 643
    • Primary completion date changed from estimate of Sep 30, 2025 to Sep 22, 2025
    • Study completion date: Dec 31, 2025 to Sep 30, 2026
    v5
  3. Primary completion date: Apr 30, 2025 to Sep 30, 2025v4
  4. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Jun 30, 2025 to Apr 30, 2025
    • Study completion date: Sep 30, 2025 to Dec 31, 2025
    • Site details revised
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2023 to Oct 22, 2023
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The recommended daily amounts of vitamins and minerals, referred to as micronutrients, are based on data from high income settings and for healthy populations do not fully correct nutritional deficiencies in undernourished settings. This study will determine the minimum acceptable doses across a range of nutrients at which sufficiency is achieved with supplementation using biochemical indicators of nutritional status in non-pregnant (non-lactating) women of reproductive age and pregnant women in Bangladesh. In this double-masked randomized controlled trial, a dose response study will be undertaken using increasing levels of doses provided as supplements to women (pregnant or non-pregnant) with nutritional indicators as outcomes.
Trial Details
NCT Number NCT06081114
Lead Sponsor Johns Hopkins Bloomberg School of Public Health
Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh, Bill and Melinda Gates Foundation
Conditions
(from sponsor)		 Micronutrient Status
Enrollment 643 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov